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FSMA Reaction blog

On November 15, the U.S. Food and Drug Administration (FDA) released its final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule). The rule defines recordkeeping requirements for those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) and provides a traceability framework suitable for all commodities, regardless of listed status. They designed these requirements to enable quicker, more precise recalls and outbreak investigations, reducing the damaging impacts of foodborne illness.  

Implementing the rule, also known as Food Safety Modernization Act (FSMA) Section 204, is a critical step toward the FDA’s goal of advancing tech-enabled traceability. “This standardized, data-driven approach to traceability recordkeeping helps create a harmonized, universal language of food traceability that will help pave the way for industry to adopt and leverage more digital, interoperable, and tech-enabled traceability systems both in the near term and the future,” remarked Frank Yiannas, the FDA’s deputy commissioner for food policy and response, during a stakeholder briefing held after the rule’s release.  

In 2012, IFT worked with the FDA under the Original Food Safety Modernization Act Section 204 Task Order to understand the traceability processes being used at the time and outline recommendations for improvement and best practices. Many of the novel concepts from that report are now foundational to the FDA’s final rule.  

The rule creation process included a public comment period, and the final rule highlights the FDA’s effort to incorporate stakeholder feedback, reflected by several changes between the proposed and final rules. For example, the FDA removed the “first receiver” concept and replaced it with “initial packing” and “first land-based receiver” critical tracking events (CTEs) that clarify data collection requirements for actors at the beginning of the supply chain. The final rule also simplified the “creation” and “transformation” CTE terms in the proposed rule by eliminating “creation” and revising the definition of “transformation.”   

FDA also significantly changed the “kill step exemption,” expanding it to include any listed food that will undergo a kill step (a process conducted to significantly minimize pertinent pathogens such as cooking, pasteurization, other heat treatments, high-pressure processing, and irradiation), as long as written agreements between trading partners ensure that the kill step will be applied by a party other than a retail food establishment, restaurant, or consumer. The full suite of exemption criteria is both intricate and extensive, which may add complexity for industry actors as they determine their responsibilities. IFT’s Global Food Traceability Center’s (GFTC) traceability experts will provide insights on these complexities and plan to develop additional resources to meet stakeholders’ diverse implementation needs throughout the supply chain.   

The GFTC aims to engage food system stakeholders in their traceability journeys through applied research, capacity building, advocacy, system design, and implementation. The final rule can reduce foodborne illness, and we look forward to participating in implementation efforts that advance the safety and traceability of our food supply. Visit the GFTC web page to find our Introduction to Traceability videos, Traceability Workbook, and other online resources, and stay tuned for new FSMA 204 tools and content coming soon. 

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